Rextar X
510(k) K132041
Rextar X is a Class II device made by Meta Biomed, Inc., cleared under FDA 510(k) K132041 on 31 Jul 2013, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK132041 | Date31 Jul 2013 | StatusActive |
Official records
- FDA 510(k) database K132041
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EHD
- Device class
- Class II
- Regulation
- 21 CFR Part 872.1800
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K132041
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| POSKOM Co., Ltd. Rextar X | Rextar X | 08800040900047 | — | On the market |
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Other devices filed under FDA product code EHD (Unit, X-Ray, Extraoral With Timer).
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- BELRAY/MODEL 096, DENTAL INTRAORAL X-RAY by Belmont Equipment Corp.
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- Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) by ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA